Human Ovarian Autotransplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Samuel Kim, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01403675
First received: July 14, 2011
Last updated: October 21, 2013
Last verified: October 2013

July 14, 2011
October 21, 2013
May 2009
December 2015   (final data collection date for primary outcome measure)
Comparision of orthotopic and heterotopic autotransplantation [ Time Frame: 2009-2015 ] [ Designated as safety issue: No ]
The main purpose of this study is to investigate restoration of ovarian function and fertility by autotransplantation of human ovarian tissue using heterotopic and orthotopic techniques
We will analyze 20 patients if any changes in breast cells afer controlled ovarian stimulation by comparing the results of baseline FNA of breast and repeat FNA [ Time Frame: 6, 12, 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01403675 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Human Ovarian Autotransplantation
Human Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer

Chemotherapy can cause permanent damage to a woman's ovaries. Women who are cancer survivors may find that they are not able to produce female hormones, and they may not be able to have a child. Scientists are trying to find ways to help cancer survivors regain their hormonal function and possibly get pregnant, if they desire. Scientists have developed a method where ovarian tissue is removed and frozen before chemotherapy; then it is thawed and put back into the woman's body after she is cancer-free. Putting a woman's previously-frozen tissue back into her body is called ovarian autotransplantation.

Ovarian autotransplantation is a very new technique, and there have only been a small number of women who have had this procedure. So far, only five babies in the world have been born using this technique.

The purpose of this study is to learn more about ovarian autotransplantation. Scientists hope to find better ways to use this method to help a woman's ovaries start working again after chemotherapy. If the ovaries start working again, it might be possible to have a baby.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Ovarian Autotransplantation Using Cryopreserved Ovarian Tissue in Women Treated for Cancer
Procedure: Ovarian autotransplantation
There are two ways to transplant the thawed ovarian tissue back into a woman's body. It can be put back inside the abdomen, close to the natural location of the ovaries, or the tissue can be put under the skin of the abdomen. After you have had the transplant, your hormone function will be tested every month. Each month, you will have a blood draw to measure hormones and an ultrasound to see how the tissue is growing. These monthly visits will continue until you have normal hormone levels. If the transplant is successful, it is expected that your hormones would return to normal in 3 - 7 months. If your hormone levels return and stay regular for three months, then Dr. Kim will talk to you about trying to get pregnant. The method of getting pregnant will depend on the type of transplantation surgery you had and your current medical condition. You will have weekly blood tests and other tests to determine the best way to get pregnant.
Experimental: Ovarian autotransplantation
Intervention: Procedure: Ovarian autotransplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Adult women (age between 18 and 40) who stored the ovary before cancer therapy.
  • Adult women who completed cancer therapy and are in remission.
  • Adult women who desire to conceive and are ready to have a baby.

Exclusion criteria:

  • Age under 18 or over 40 years old
  • Women with a disease at high risk for ovarian metastasis (such as leukemia)
  • Women with contraindication for surgery
  • Women with contraindication for pregnancy
  • Psychological instability to sustain pregnancy (diagnosed by a psychiatrist)
  • Women who are HIV Positive
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01403675
11214
Yes
Samuel Kim, MD, University of Kansas Medical Center Research Institute
Samuel Kim, MD
Not Provided
Principal Investigator: Sam Kim, MD The University of Kansas Medical Center
University of Kansas
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP